Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.

FDA DeterminedCause 2

DESIGN: Labeling Design

Action

November 7, 2013 all consignees were notified of the Urgent Device recall via telephone calls and E-mail messages describing the product and reason for the recall,. The notice included directions to identify and quarantine the recalled devices returning product to OrthoPediatrics with completed return form to OrthoPediatrics via mail, email or courier service, or by
photographing with a smart phone and emailing to logistics@orthopediatrics.com or by answering the
recall specific questionsin an email to mfox@orthopediatrics.com.

Quantity in Commerce

40

Distribution

Nationwide Distribution including the states of CA, KY, OH, RI, and TN.